Investigation of fibrinogen in early bleeding of patients with newly diagnosed acute promyelocytic leukemia

Abstract

Early hemorrhagic death remains a major cause of treatment failure in acute promyelocytic leukemia (APL). This study investigated the role of fibrinogen concentrations in early hemorrhage and overall survival (OS) of APL patients. Laboratory and clinical data, including fibrinogen concentrations and other coagulation indexes, bleeding events, and survival data, of 198 patients newly diagnosed with APL from February 2012 to December 2017 were extracted from patient records and retrospectively investigated. Patients with moderate/severe bleeding had significantly lower median fibrinogen concentrations (p = .023), higher Chinese disseminated intravascular coagulation scoring system (CDSS) (p < .001), and were more often female (p = .034) than patients with no such bleeding. Additionally, patients with fibrinogen <1.0 g/L and 1.0–1.6 g/L had significantly higher moderate/severe bleeding rates than those with fibrinogen >1.6 g/L (p = .015; p = .023). However, moderate/severe (p = .088) and severe bleeding rates (p = .063) were comparable for patients with fibrinogen <1.0 g/L and 1.0–1.6 g/L. Multivariate analysis showed that fibrinogen ≤1.6 g/L (p = .036), platelet counts ≤10 × 10⁹/L (p = .037), and CDSS scores ≥5 (p = .023) were independent risk factors for moderate/severe bleeding. Survival analysis indicated that moderate/severe bleeding (p = .018), fibrinogen ≤1.6 g/L combined with prothrombin time >12.8 s (p = .005), age ≥60 years (p = .001), and CDSS ≥5 (p = .044) were independent predictors of 1-year OS. Fibrinogen ≤1.6 g/L may be an independent risk factor for early bleeding in newly treated patients with APL and is associated with a worse 1-year OS. Increasing fibrinogen to >1.6 g/L may help to prevent bleeding.

Keywords:

• Acute promyelocytic leukemia
• bleeding
• fibrinogen
• overall survival

Author Contributions

Tiantian Chu collected and analyzed the data, and wrote the manuscript. Hong Wang and Jiaqian Qi participated in data analysis. Xin Lv participated in data collection. Yue Han and De-pei Wu conceived of and designed the study and are the corresponding authors. All authors have reviewed the manuscript. All authors have read and approved the final manuscript.

Acknowledgements

We would like to thank the patients and physicians from the Department of Hematology, The First Affiliated Hospital of Soochow University.

Disclosure of Interest

The authors report no conflict of interest.

Ethics Approval

This retrospective chart review study involving human participants was performed in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This study was approved by the Committee for the Ethical Review of Research at First Affiliated Hospital of Soochow University.

Informed Consent

The Committee for the Ethical Review of Research at First Affiliated Hospital of Soochow University approved this study and waived the need for informed consent for this retrospective analysis. The participants have consented to the submission of the study to the journal.

Additional information

Funding

This work was supported by the National Natural Science Foundation of China (81873432 and 81670132), grants from the Jiangsu Province of China (BE2016665, 18KJA320006, and ZDRCA2016047), the Jiangsu Provincial Special Program of Social Development (SBE2016740635), and the Priority Academic Program Development of Jiangsu Higher Education Institutions (PAPD).